*W2 ONLY*
Sr. Regulatory Affairs Specialist (12 month contract // Boulder, CO or Minneapolis, MN):
Candidate is required to work on site in Boulder, CO or Minneapolis, MN at least 3 days per week
Open to fully remote for strong candidates
HM's Top Needs:
- Experience with US and EU change assessments
- Experience reviewing and support MDR Clinical Evaluation documentation as a Regulatory stakeholder (not necessarily as an author)
- Willingness to be adaptive, collaborative, and supportive of the Regulatory team
Education/Experience Required: Bachelor’s with 4+ years’ experience in RA, advanced degree with 2+ years’ experience in RA
Duties:
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
- Leads or compiles all materials required in submissions, license renewal and annual registrations.
- Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Monitors and improves tracking / control systems.
- Keeps abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters.
- Recommends strategies for earliest possible approvals of clinical trials applications.
Must Have:
- 2-4+ years’ experience in regulatory (medical devices)
- Strong experience with change assessments for EU/US marketed products
- Strong organizational skills to manage multiple projects simultaneously under limited supervision
- Analytical thinking to identify potential regulatory issues and develop effective solutions.
- Demonstrated excellent organizational skills
- Demonstrated technical writing skills
- Excellent attention to detail
- Excellent communication skills
- Experience as regulatory lead in core teams for sustaining and development projects
- Expert proficiency in Microsoft Office suite, including Word and Excel
- Proficient at managing multiple projects at once
- Regulatory assessment of change orders emphasis on US and EU
- Familiar with ISO 13485, FDA Medical Devices Part 820, and Medical Device Good Documentation Practices
Nice to Have
- 510(k) authorship
- Adobe software skills
- RAPS Regulatory Affairs Certification (RAC)